MAUDE Adverse Event Report: SYNTHES HAGENDORF APPLICATION INSTRUMENT FOR STERNAL ZIPFIX; N/A

Catalog Number 03.501.080

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 10/28/2016

Event Type  Injury  

Manufacturer Narrative

Patient information is not available for reporting.Device is an instrument and is not implanted / explanted.Device is expected to be returned for manufacturer review/investigation, but has not been received yet.(b)(4).No service history review can be performed as part number 03.501.080 with lot number 8725319 is a lot/batch controlled item.The release to warehouse date of this item is dec 03, 2013.The service history review is unconfirmed.Device history records review was completed for part # 03.501.080, lot # 8725319.Manufacturing site: (b)(4), manufacturing date: nov 26, 2013.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that a patient previously underwent coronary bypass surgery on an unknown date and non-synthes wire was used to close the sternum.On (b)(6) 2016, the patient was brought back to the operating room for a revision sternotomy and a redo of his coronary artery bypass.As the surgeon went to re-tighten the three (3) zipfix ties he used to close the sternum, the application instrument for the sternal zipfix malfunctioned.It was described that the device became stuck and would not tighten the ties.There was not another application instrument available and the surgeon chose to augment the patient with two (2) sternal plates and approximately twelve (12) screws.There was a several minute delay in the surgery due to the issue.The patient was reported as stable.Concomitant device: sternal zipfix with needle sterile.This report is for one (1) application instrument for sternal zipfix.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

A service and repair evaluation was completed: the customer reported the tightening mechanism broke.The repair technician reported the retaining nut was loose.Loose component is the reason for repair.The cause of the issue is unknown.No parts were replaced.The item was repaired per the inspection sheet, passed synthes final inspection and will be returned to the customer upon completion of the service and repair process.The evaluation was confirmed.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Correction to concomitant device reported: sternal zipfix with needle sterile (part unknown, lot unknown, quantity 3).

Manufacturer Narrative

Height (b)(6).Exact weight (b)(6).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: APPLICATION INSTRUMENT FOR STERNAL ZIPFIX
• Type of Device: N/A
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6112827
• MDR Text Key: 60359813
• Report Number: 3003875359-2016-10604
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 03.501.080
• Device Lot Number: 8725319
• Other Device ID Number: (01)10887587010847(10)8725319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/28/2016
• Initial Date FDA Received: 11/18/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/15/2016; 12/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNKNOWN QUANTITY OF UNKNOWN STERNAL ZIPFIX
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 76